AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]

AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: January 30, 2009)

Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Fasting Conditions

Brief Summary

The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.

All subjects selected for this study will be at least 18 years of age.

Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.

Each female subject will be give a serum pregnancy test as part of the pre-screening process.

Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.

Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria:

Subjects with a history of alcoholism or drug addiction (during past 2 years), or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.

Subjects whose clinical laboratory test values are outside the normal range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.

Subjects who have a history of allergic responses to the class of drug being tested should be excluded form the study.

All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.

Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.

Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.

Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study dosing, or used oral hormonal contraceptives within 14 days before dosing will not be allowed to participate.

All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects